MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122158

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Injury (2348); No Code Available (3191)

Event Date 01/23/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.

Manufacturer Narrative

It was reported that hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.Using the supplied implantation dates and hospital name and known details of the bhr cup, the bhr head involved in this case has been preliminarily identified (subject to confirmation with medical records).The device identified was as follows: 74123152, lot 16lw08506 52mm head in the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Without the requested clinical relevant documents we are unable to conduct a thorough medical assessment.Therefore, no medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: BHR RESURFACING ACETABULAR CUP 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8277071
• MDR Text Key: 134075405
• Report Number: 3005975929-2019-00029
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Catalogue Number: 74122158
• Device Lot Number: 16KW15065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 52MM FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD 52MM 74123152/16LW08506; 52MM FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention